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LDK378 Versus Chemotherapy in Previously Untreated Patients With ALK Rearranged Non-small Cell Lung Cancer

NCT01828099 · Status: COMPLETED · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 376

Last updated 2025-01-16

Study results available
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Summary

To compare the efficacy and safety of ceritinib with standard first-line chemotherapy (pemetrexed plus cisplatin or carboplatin) in patients with stage IIIB (not candidates for definitive multimodality therapy) or stage IV, non-squamous non-small cell lung cancer (NSCLC) harboring a confirmed anaplastic lymphoma kinase (ALK) rearrangement, using the Ventana immunohistochemistry (IHC) test.

Conditions

Interventions

DRUG

Ceritinib

Ceritinib was administered orally once-daily fasted at a dose of 750 mg capsules on a continuous dosing schedule.

DRUG

Pemetrexed

Pemetrexed was administered at a dose of 500 mg/m\^2 as an intravenous (iv) infusion on Day 1 of each 21-day cycle

DRUG

Cisplatin

Cisplatin was administered by iv infusion at a dose of 75 mg/m\^2 every 21 days for up to 4 cycles.

DRUG

Carboplatin

Carboplatin was administered as iv infusion (AUC 5-6) every 21 days up to 4 cycles

Sponsors & Collaborators

Principal Investigators

  • Novartis Pharmaceuticals · Novartis Pharmaceuticals

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
100 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2013-07-09
Primary Completion
2016-06-24
Completion
2024-01-07
FDA Drug
Yes

Countries

  • Argentina
  • Australia
  • Austria
  • Brazil
  • China
  • Colombia
  • Denmark
  • France
  • Germany
  • Greece
  • Hungary
  • India
  • Ireland
  • Italy
  • Japan
  • Lebanon
  • Mexico
  • Netherlands
  • Norway
  • Poland
  • Russia
  • Singapore
  • South Korea
  • Spain
  • Sweden
  • Taiwan
  • Thailand
  • Turkey (Türkiye)
  • United Kingdom

Study Locations

More Related Trials

Entities

Drugs
Diseases
Companies

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT01828099 on ClinicalTrials.gov